Determine the effectiveness of PST on the mental health of women after spontaneous abortion.
Design
Clinical trial with control group, randomized with quadruple blocks, The sample size was considered as 46.
Settings and conduct
The sampling sites are the gynecology and obstetrics departments of Razi and Imam Khomeini hospitals and Ahvaz health centers. By referring to existing medical records, the address and telephone number of women who have spontaneous abortion in the past 1 to 6 months are listed and Invited by phone call, a briefing is to be held and After obtaining written consent and ensuring confidentiality of information, The mental health questionnaire is completed by people who have the criteria for entering the study. Meetings are held in the classroom located in the Department of Women's Surgery, Razi Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1.minimum 4 weeks and Maximum 6 months have passed since their abortion.
2.In the first pregnancy, abortion occurred.
3.Having at least elementary education
4. Informed consent to participate in the study
5- Earning a score above 65 from the mental health questionnaire
Exit criteria:
1.Missing pregnancy is unwanted
2.Drug and psychedelic consumption
3.A history of chronic medical and psychological illnesses, and
4. Mother's disability or having a disabled child
5.The use of psychoactive drugs
6.The experience of an unfortunate incident, such as the death of a first-degree relative, in the past six months
7.Cognitive-behavioral therapy and any psychological intervention within the last 12 weeks
8.Current pregnancy and lactation
Intervention groups
For the intervention group, 1 individual counseling session and 8 group sessions will be held using the problem-solving treatment method. after the research, the control group will receive 2 intensive counseling sessions.
Main outcome variables
mental health
General information
Reason for update
Acronym
PST سه حرف درمان حل مسئله
IRCT registration information
IRCT registration number:IRCT20181129041792N1
Registration date:2019-02-03, 1397/11/14
Registration timing:registered_while_recruiting
Last update:2019-02-03, 1397/11/14
Update count:0
Registration date
2019-02-03, 1397/11/14
Registrant information
Name
Roghayeh nazaralivand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3653 2786
Email address
nazaralivand.r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-08, 1397/09/17
Expected recruitment end date
2019-03-15, 1397/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of problem-solving based treatment on women's mental health after spontaneous abortion
Public title
Investigating the problem-solving treatment on the mental health of women after spontaneous abortion.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
At least 4 weeks and at most 6 months have passed since their abortion.
In the first pregnancy, abortion occurred.
Having at least elementary education
Conscious Consent to Participate in the Study
Exclusion criteria:
Unwanted missing pregnancy.
Drug and psychedelic substances consumption
A history of chronic medical and psychological illnesses,
Mother's disability or having a disabled child
The use of psychoactive drugs such as antidepressants, anti-psychosis and ...
The experience of bad events such as the death of a first-degree relative, in the past six months
Cognitive-behavioral therapy and any psychological intervention within the last 12 weeks
Current pregnancy and lactation
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning people to the control and test groups is randomized and quadruple blocks (using the table for random permutations). After determining the block size in this study, the block list is provided and the number assigned to them, then random numbers will be chosen between 1 and 6.
AABB(1), ABAB(2), ABBA(3), BBAA(4), BABA(5), BAAB(6)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz University of Medical Sciences
Street address
Golestan Highway, Ahwaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2018-11-17, 1397/08/26
Ethics committee reference number
IR.AJUMS.REC.1397.616
Health conditions studied
1
Description of health condition studied
Spontaneous Abortion
ICD-10 code
O03
ICD-10 code description
Spontaneous abortion
Primary outcomes
1
Description
mental health
Timepoint
Before the intervention begins and then one month after the end of the intervention
Method of measurement
Mental Health Questionnaire The symptoms checklist-25
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, an individual meeting and 8 group sessions of 23 persons are conducted on a weekly 90-minute basis by consulting a problem-solving methodology researcher and supervised by an advisor in the classroom located in the Department of Women's Surgery, Razi Hospital.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital
Full name of responsible person
Sasan Mogahie
Street address
Shahid Ahwazian Street, 24 meters to the black bridge
City
Ahvaz
Province
Khouzestan
Postal code
6845157971
Phone
+98 61 3222 2818
Email
nazaralivand@gmail.com
2
Recruitment center
Name of recruitment center
Ahvaz Razi Hospital
Full name of responsible person
Farhang Kore Bandi
Street address
Ahwaz, Amanyeh, Palestine Street
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 5935
Fax
Email
nazaralivand@gmail.com
3
Recruitment center
Name of recruitment center
Ahvaz West Health Center
Full name of responsible person
Mehrdad Sharifi
Street address
Takhty Alley, Bahman Avenue
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3311 2786
Email
nazaralivand@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mitra Tadayon Najaf Abadi
Street address
Ahvaz, Ahvaz, Golestan, Jundishapur University
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 7543
Email
nazaralivand@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mitra Tadayn Najaf Abadi
Position
Faculty of Nursing and Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ahvaz Ahwaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6845157971
Phone
+98 66 3653 2786
Fax
Email
tadayon-m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mitra Tadayn Najaf Abadi
Position
Faculty of Nursing and Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ahvaz Ahwaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6845157971
Phone
+98 66 3653 2786
Fax
Email
tadayon-m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Roghayeh Nazaralivand
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Baharan Ave., Golesjane sizdahom st.
City
Roomeshgan
Province
Lorestan
Postal code
6845157971
Phone
+98 66 3653 2786
Fax
Email
nazaralivand.r@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available